Ampicillin-Sulbactam Injection Recalled Due to Sterility Concerns
FDA recalls Ampicillin and Sulbactam for Injection (1.5 grams per vial) manufactured by Astral SteriTech due to lack of sterility assurance. The recall affects 236,610 vials distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of injectable medication due to manufacturing defect—lack of sterility assurance. No illnesses or injuries have been reported. Per the rubric, risk-of-harm products without reported injury score at maximum 3 (High).
Plain-English summary
Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial (NDC 71288-005-20), manufactured by Astral SteriTech Private Ltd. for Meitheal Pharmaceuticals, is being recalled. The recall affects 236,610 vials distributed nationwide within the United States.
The recall was initiated due to lack of assurance of sterility. The manufacturer could not provide adequate assurance that all manufactured vials meet required sterility standards.
Healthcare providers and pharmacies that may have received this product should check their inventory for affected vials. Patients who have concerns about medications they have received should consult their healthcare provider. All lots currently within expiration are included in this recall.
The recalled product
- Product
- Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20
- Manufacturer
- Astral SteriTech Private Ltd.
- Category
- Drug — Injectable Antibiotic
- Affected units
- 236,610
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots within expiry.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 52 recalled by Astral SteriTech Private Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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